The following data is part of a premarket notification filed by Ge Medical Systems, Inc. with the FDA for Ge 3.0t General Purpose Flex Coil.
| Device ID | K030953 |
| 510k Number | K030953 |
| Device Name: | GE 3.0T GENERAL PURPOSE FLEX COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Larry Kroger |
| Correspondent | Larry Kroger GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee, WI 53201 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-27 |
| Decision Date | 2003-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682121620 | K030953 | 000 |
| 00840682104937 | K030953 | 000 |